Cardiac RadiothErapy for VEntricular Tachycardia II
ConditionVentricular Tachycardia (VT)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
Steoreotactic therapy radioablation has become a standard of care option for patients with therapy-refractory ventricular tachycardia, yet long-term outcome is lacking. The objective of this study is to evaluate the long-term outcomes, both efficacy and safety, after STAR in patients with therapy-refractory ventricular tachycardia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Eligible for STAR for therapy-refractory VT based on a multidisciplinary discussion
Ability to give a written informed consent and willingness to return for follow-up
Disqualifiers
Contra-indications for STAR, including pregnancy or breastfeeding, previous radiotherapy with cardiac involvement, life-expectancy < 6 months in the absence of VT
Any condition that is deemed a contraindication in the judgment of the investigators
Trial population
All patients with therapy-refractory ventricular tachycardia who are scheduled for stereotactic radiotherapy ablation (STAR) are eligible for participation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
stereotactic radiotherapy ablation
Procedure/SurgerySingle dose of 25 Gy up to 32.5 Gy on the myocardium in patients with therapy-refractory ventricular tachycardia
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change in VT burden
Change in VT burden, measured as the frequency of appropriate ICD interventions or documented VT episodes over a 48-month follow-up period. The ICD interrogations are part of standard of care and the majority of patients are included in remote monitoring which automatically sends new VT episodes to the telemonitoring team. The efficacy of STAR will be assessed by analysing both the total VT burden, but also time to first VT event (with and without a 6 week blanking period).
Time frame
48 monthsSecondary outcomes
1
Quality of Life
The 36-Item Short Form Survey (SF-36) is a set of generic, coherent, and easily administered quality of life measures that rely on patient self-reporting. The SF-36 evaluates 8 domains: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scale values for each domain range from 0 to 100 where the higher score defines a more favorable health state over a 48-month follow-up period.
Time frame
Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months2
All-cause mortality
Survival will be tracked during the 48-month follow-up period. In case of mortality, the cause of death will be registered.
Time frame
48 months3
Radiotherapy toxicity
The tolerable acute toxicity rate is defined as a 30-days follow-up without treatment-related grade ≥ 3 adverse events. Late toxicity is defined as toxicity occurring after at least 30 days after the radiation treatment. Toxicity will be assessed by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Time frame
48 months4
Left ventricular function
Left ventricular function on transthoracic echocardiogram (TTE) by measuring left ventricular ejection fraction.
Time frame
Baseline and at each follow-up moment: 1 month, 2 months, 3 months, 6 months, 12 months, 24 months, 36 months, 48 monthsSponsors and contacts
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Source ClinicalTrials.gov